Vertex Announces Dr. Jeffrey Leiden to Transition to Role of Executive Chairman, Effective April 1, 2020 and Dr. Reshma Kewalramani Appointed as New Chief Executive Officer

On July 25, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that its Board of Directors has approved the planned transition of Chairman, President and Chief Executive Officer Jeffrey Leiden, M.D., Ph.D, into the role of Executive Chairman of the Board, effective April 1, 2020 (Press release, Vertex Pharmaceuticals, JUL 25, 2019, View Source [SID1234537753]). At that time, Vertex’s Chief Medical Officer Reshma Kewalramani, M.D., will become President and Chief Executive Officer and will be appointed to serve on the company’s Board of Directors.

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"Jeff’s leadership has transformed Vertex and delivered extraordinary value for patients and shareholders through the discovery, development and commercialization of multiple transformative medicines. Vertex has never been stronger and is well-positioned for the future with a clear and differentiated research and business strategy, an exceptionally strong financial position, a deep leadership team, and an inclusive culture of innovation," said Bruce I. Sachs, Lead Independent Director of Vertex’s Board. "The Board of Directors is immensely grateful to Jeff for his strategic vision and relentless dedication to science and serial innovation, which has both transformed the treatment of cystic fibrosis and produced a pipeline of breakthrough medicines for other serious diseases. The Board looks forward to Jeff’s ongoing leadership and strategic guidance in his role as Executive Chairman."

Sachs continued, "The Board has been working with Jeff for several years to plan for a smooth and effective leadership transition that will ensure strategic and operational continuity for Vertex. The entire Board is excited that Reshma will become Vertex’s next CEO. She is an accomplished scientist and physician with more than 20 years of experience in medicine and biotechnology, and has a deep understanding and appreciation of Vertex’s strategy, business and culture."

"It has been a tremendous privilege to lead Vertex and our outstanding senior leadership team since 2012. I look forward to playing a continued, active role in the company over the next several years, and supporting Reshma and our team through this transition," said Dr. Leiden. "Having worked closely with Reshma for the last several years, I know that she is tremendously talented, extremely passionate about our patient-centric mission, and fully prepared to lead Vertex as we enter our next phase as a company. Her background as a physician/scientist gives her a deep understanding of the core of Vertex – our outstanding science and commitment to serial innovation. She also is a strong, collaborative leader with a proven ability to execute against our strategy to deliver results. Importantly, she has a track record of putting patients first and driving innovation to have a transformative impact on patients’ lives."

Dr. Kewalramani commented, "I am honored to become Vertex’s next CEO and to continue to work alongside Jeff, the Board and our leadership team at a time of such opportunity for the company. Consistent execution of our strategy has produced a leading portfolio of products for CF that will potentially treat up to 90 percent of patients with the disease; a productive research engine that has already led to an enviable clinical stage pipeline of potentially breakthrough medicines in five additional diseases, including Alpha-1 Antitrypsin Deficiency, Pain, Sickle Cell Disease, Beta Thalassemia, and APOL1-mediated kidney diseases; and the financial strength to continue to invest in future innovation. Most importantly, we have a talented and dedicated team of people across the company that I will be incredibly proud to lead."

Dr. Kewalramani joined Vertex in February 2017 and currently serves as the company’s Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer. In this role, she oversees clinical development, medical affairs, drug safety and other related functions, and is responsible for developing, advising and driving execution of Vertex’s clinical development programs. Prior to Vertex, Dr. Kewalramani spent more than 12 years at Amgen where she held a variety of roles across Research and Development, including as Vice President, Global Clinical Development, Nephrology & Metabolic Therapeutic Area and Vice President, U.S. Medical Organization, a group she established and grew to assume responsibility for the full portfolio of molecules across six therapeutic areas.

Dr. Kewalramani completed her internship and residency in Internal Medicine at the Massachusetts General Hospital and her fellowship in Nephrology at the Massachusetts General Hospital and Brigham and Women’s Hospital combined program. She received her medical degree, with honors, from the Boston University School of Medicine. Dr. Kewalramani also completed the General Management Program at Harvard Business School and is an alumnus of the school. She is the industry representative to the FDA’s Endocrine and Metabolic Drug Advisory Committee.

Dr. Leiden has agreed to serve as Executive Chairman through the first quarter of 2023.

Blueprint Medicines to Report Second Quarter 2019 Financial Results on Thursday, August 1, 2019

On July 25, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, August 1, 2019 to report its second quarter 2019 financial results and provide a corporate update (Press release, Blueprint Medicines, JUL 25, 2019, View Source [SID1234537752]).

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To access the live conference call, please dial (855) 728-4793 (domestic) or (503) 343-6666 (international), and refer to conference ID 1096287. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

EDAP TMS Pre-Announces Strong 98% Growth in HIFU sales in the Second Quarter 2019

On July 25, 2019 EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, reported preliminary unaudited revenues for the second quarter ended June 30, 2019 (Press release, EDAP TMS, JUL 25, 2019, View Source [SID1234537751]).

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Preliminary total revenue for the second quarter 2019 totaled EUR 12.5 million, a 45% year-over-year increase. Growth in total revenue includes strong 98% growth in HIFU sales, which totaled EUR 4.6 million for the second quarter.

Year-to-date through June 30, 2019, the Company reported 27% growth in total revenue over the comparable period in 2018, driven primarily by a strong 78% increase in HIFU sales.

Marc Oczachowski, EDAP’s Chief Executive Officer, commented, "We are very happy to report preliminary second quarter revenue showing continued momentum and traction in HIFU sales. We reported 98% growth in HIFU sales for the second quarter 2019 compared to second quarter 2018, driven by the sale of five HIFU devices, including three in the U.S. Our revenue performance was also driven by strong growth in HIFU treatment revenue, which increased 51% in the quarter. We look forward to reporting our full second quarter financial and operating results during our earnings call on Thursday, August 29."

EDAP TMS will release its financial results for the second quarter ended June 30, 2019 after the financial markets close on Wednesday, August 28, 2019.

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT on Thursday, August 29, 2019. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Thursday August 29th @ 8:30am Eastern Time
Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13693076
Webcast: View Source

Verastem Oncology to Announce Second Quarter 2019 Financial Results and Corporate Update on August 1, 2019

On July 25, 2019 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that the Company will host a conference call and webcast on Thursday, August 1, 2019 at 4:30 p.m. Eastern Time to discuss corporate updates and financial results for the second quarter ended June 30, 2019 (Press release, Verastem, JUL 25, 2019, View Source [SID1234537750]).

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The call can be accessed by dialing (877) 341-5660 (U.S. and Canada) or (315) 625-3226 (international), five minutes prior to the start of the call and providing the passcode 6256817. The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

4SC AG: Positive safety review of Phase Ib/II EMERGE study of domatinostat + avelumab in gastrointestinal cancer

On July 25, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported, that the Safety Review Committee consisting of clinical and drug safety experts evaluated the safety data from the first dose cohort and recommended continuation with the second dose cohort in the ongoing Phase Ib/II EMERGE study (ClinicalTrials.gov identifier: NCT03812796) (Press release, 4SC, JUL 25, 2019, View Source [SID1234537749]). Patient recruitment for the second dose cohort has been initiated. The study is being conducted by Prof. David Cunningham, MD FRCP FMedSci, Head of the Gastrointestinal and Lymphoma Unit and Director of Clinical Research at The Royal Marsden NHS Foundation Trust (London, UK).

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The multi-center, single-arm, open-label study initiated in January 2019, is a dose escalation study, conducted initially in up to 15 patients with microsatellite-stable gastrointestinal cancer. The study evaluates domatinostat in combination with the checkpoint inhibitor avelumab. The study is conducted in two parts, an initial part to evaluate the safety of domatinostat in combination with a checkpoint inhibitor and to determine a recommended Phase II dose, potentially followed by a second "expansion" part in order to obtain a larger data-set through the addition of more patients at the preferred dose.

Prof. Cunningham said: "Safety and tolerability are key requirements for patients and physicians considering a drug. We are encouraged by the positive outcome of the first safety review and are looking forward to enrolling patients into the second dose cohort, especially as checkpoint inhibitors alone so far have not shown clinical activity in patients with microsatellite-stable gastrointestinal cancer."

Jason Loveridge, Ph.D., CEO of 4SC, added: "We are happy to support investigator-sponsored research conducted by third parties on our drug candidates. This research can provide valuable information regarding the safety, efficacy, pharmacology and tolerability of 4SC’s drug candidates and supplement the data generated in our own clinical studies, such as the SENSITIZE trial of domatinostat in combination with pembrolizumab, another checkpoint inhibitor, in patients with advanced-stage melanoma.

We plan to initiate several clinical trials of domatinostat in combination with checkpoint inhibitors both in melanoma and Merkel cell carcinoma (MCC) in late 2019 and early 2020 with the intention that one of the MCC studies would be potentially sufficient for registration purposes."